NCT01625143

Brief Summary

This laboratory study is looking into genes in samples from younger patients with relapsed acute lymphoblastic leukemia. Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors find better ways to treat cancer.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

June 17, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 21, 2012

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Last Updated

May 18, 2016

Status Verified

May 1, 2016

Enrollment Period

3.9 years

First QC Date

June 17, 2012

Last Update Submit

May 17, 2016

Conditions

B-cell Childhood Acute Lymphoblastic LeukemiaRecurrent Childhood Acute Lymphoblastic LeukemiaUntreated Childhood Acute Lymphoblastic Leukemia

Outcome Measures

Primary Outcomes (3)

  • Cellular origins of relapse and the underlying epigenetic mechanisms associated with drug resistance

    1 month

  • Genes associated with histone modification

    1 month

  • Biological pathways involved in relapse

    1 month

Study Arms (1)

Observational

Archived bone marrow samples, collected at the time of diagnosis and relapse, are analyzed for gene expression and histone modifications by microarray, chromatin immunoprecipitation (ChIP) sequencing, and quantitative real-time polymerase chain reaction (qRT-PCR).

Other: laboratory biomarker analysis

Interventions

laboratory biomarker analysisOTHER

Correlative studies

Observational

Eligibility Criteria

AgeUp to 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Diagnosis of B-cell acute lymphoblastic leukemia

You may qualify if:

  • Diagnosis of B-cell acute lymphoblastic leukemia
  • Paired diagnosis-relapse primary patient samples obtained from the Children's Oncology Group (COG) cell bank

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Oncology Group

Arcadia, California, 91006-3776, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Archived bone marrow samples

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • William Carroll, MD

    Children's Oncology Group

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 17, 2012

First Posted

June 21, 2012

Study Start

June 1, 2012

Primary Completion

May 1, 2016

Last Updated

May 18, 2016

Record last verified: 2016-05

Locations

US(1)